The Influence of Feeding Source on the Gut Microbiome and Time to Full Feeds in Neonates With Congenital Gastrointestinal Pathologies
Launched by SEATTLE CHILDREN'S HOSPITAL · Oct 3, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at how different types of feeding can affect the health of newborns who have certain gut conditions, like intestinal blockages or specific birth defects. Researchers want to compare the outcomes of feeding these infants an exclusive diet of human milk versus standard feeding practices. The goal is to see which type of feeding helps improve their gut bacteria and how quickly they can start eating fully.
To participate, infants must have certain conditions like gastroschisis or Hirschsprung disease and must be under 6 months old. However, infants who are too premature (born before 34 weeks) or who have had any feedings before the study cannot join. If families choose to participate, they will help researchers learn more about the best feeding methods for these vulnerable babies, which could lead to better care in the future. It's also important to note that while some substances like marijuana might be allowed, others, like certain drugs, are not.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Infants with gastroschisis, giant omphalocele, intestinal atresia, mid-gut volvulus, hirschsprungs disease.
- Exclusion Criteria:
- • 1. Infant has already been on feeds
- • 2. Infants \<34 weeks gestation
- • 3. Parents with contraindications to providing milk (i.e. drug use-cocaine, fentanyl, meth BUT oxy/suboxone/marijuana OK)
- • 4. Complicated gastroschisis
- • 5. Short gut syndrome
- • 6. Additional congenital anomalies that affect ability to tolerate milk (i.e. cyanotic congenital heart disease BUT kidney disease ok)
About Seattle Children's Hospital
Seattle Children's Hospital is a leading pediatric healthcare institution dedicated to advancing the health and well-being of children through innovative clinical research and trials. As a prominent sponsor of clinical studies, the hospital focuses on developing new treatments and therapies that address the unique medical needs of children. With a commitment to excellence, Seattle Children's Hospital collaborates with a network of researchers, healthcare professionals, and academic institutions to ensure rigorous scientific standards and ethical practices in all its clinical investigations. By prioritizing patient safety and scientific integrity, the hospital aims to contribute to the global body of knowledge in pediatric medicine and improve outcomes for children with various health conditions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Seattle, Washington, United States
Patients applied
Trial Officials
Katie Strobel, MD
Principal Investigator
Seattle Children's Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported